This contemporary series of 7,372 consecutive patients undergoing new-device angioplasty, including the newer-generation balloons, demonstrates significant gender differences in clinical outcomes. Despite similar angiographic and procedural success rates, women have higher periprocedural mortality and tend to have more overall complications than men. Gender differences in baseline characteristics may be contributing to the worse outcome among women. However, female gender remains an independent predictor of in-hospital mortality after new-device angioplasty in this registry. Although women had a higher mortality than men at 1-year follow-up, by multivariate analysis, female gender was not associated with long-term mortality in our registry.
The greatest impact of new devices including the newer-generation balloons has been the overall improvement in procedural and angiographic success rates. With the original balloon angioplasty devices available before 1985, the range of procedure success was 60–70% and improved to 80–90% after 1985. 1,3,14–16 In the current study, procedure success was further improved with new-device angioplasty in both men and women (>92%). Although women continue to have a higher mortality than men, in-hospital mortality rates in women undergoing new-device angioplasty (<1.5%) remain comparable and possibly lower than previously reported rates (up to 4.1%) associated with balloon angioplasty alone. 1,3,15–17
Clinical factors are known to contribute to the higher morbidity and mortality in women after revascularization procedures; however, adjusting for age and other comorbid conditions does not always completely eliminate the differences in outcomes. 2–4,15 Differences in vessel size and body surface area (BSA) have long been held to be important factors contributing to the apparent gender discrepancy in outcome. 18 In the NHLBI PTCA registries, men of short stature had rates of mortality similar to those of women. 1,3 In a series of 5,000 angioplasty patients from the Cleveland Clinic, women’s increased in-hospital mortality (1.1%vs 0.3%, P = 0.001) was no longer significant after correcting for differences in BSA. 17 The higher mortality associated with a smaller BSA is presumably due to higher procedural complications such as dissections and perforations. Specific cause and effect have yet to be elucidated.
As in most prior angiographic reports, the women in this study had smaller vessel size than men (2.66 ± 0.60 vs 2.81 ± 0.64 mm, P = 0.0008); however, in contrast to other angiographic studies in which differences in mortality were abolished after correcting for differences in body surface area or vessel caliber, 19,20 the current study still identified women to have an inherent risk of mortality after coronary intervention. Whether women have an inherent biological risk or whether the excess mortality is the result of other procedure-related factors that were not specifically measured is not clear. For example, the higher incidence of congestive heart failure in the context of a higher left ventricular ejection fraction suggests more diastolic dysfunction among women. The implications of diastolic dysfunction and congestive heart failure on postprocedure complications including mortality, and the impact of the contrast load, are not well defined. Ongoing studies are currently evaluating device-specific outcomes in women to determine whether the specific device selection affects mortality.
Vascular complications were more frequent in women likely as a result of the aggressive anticoagulation regimen and the infrequent use of weight-adjusted heparin dosing during the time period of the study. In addition, sheath size has rarely been adjusted during intervention of female patients despite their smaller body size. This practice has now evolved with use of smaller sheath sizes as a result of the smaller profile of newer third- and fourth-generation devices. With the advent of adjunctive pharmacology with IIb/IIIa inhibitors, weight-adjusted heparin is now a more common practice. Whether these changes in practice have made an impact on vascular complication rates requires further study.
Paradoxically, although small vessel size and small postprocedural lumen diameters are typically associated with higher restenosis rates at follow-up after balloon or new-device angioplasty, 21–25 women are consistently reported to have target vessel revascularization rates that are similar to or lower than those of men. 3,17,26,27 In this series, the 1-year TLR and major adverse clinical event rates were lower in women, and male gender was actually an independent risk for follow-up events. Although gender differences in restenosis rates have not been well defined, lower follow-up revascularization rates among women have been reported in previous angioplasty series. 1,16,26 This may reflect a true reduction in the need for repeat revascularization in women or a potential referral bias, in which women are less likely, because of differences in symptoms or noninvasive test results or other reasons, to be referred or admitted for subsequent revascularization.
The mortality at 1 year after new-device angioplasty was higher for women than for men (4.39%vs 3.26%, P = 0.018); independent predictors included diabetes mellitus, unstable angina at the time of intervention, and prior myocardial infarction, but not gender. The late outcome after new-device angioplasty in this registry compares favorably with prior reports in patients undergoing balloon angioplasty (3.7–10.8%). 2,3,15
Despite the large number of patients included, this study has inherent limitations associated with a retrospective analysis. In addition, this analysis does not provide a device-specific evaluation. Although we report the overall impact of new devices on gender-based outcome, the results are not generalizable to a specific angioplasty device. Although the study evaluates outcomes with new devices, it does not necessarily reflect current (2002) practice patterns, in which a majority (>70%) of coronary interventions now include the use of stents and increasing use of adjunctive antiplatelet pharmacotherapy with glycoprotein IIB/IIIA inhibitors.
Women undergoing new-device angioplasty have more comorbid disease, and a slightly but significantly higher in-hospital mortality and complication rate, compared with men. However, compared with balloon angioplasty series, the procedural success has increased and mortality has decreased with the availability of new devices. Late clinical outcomes of women with new-device angioplasty are favorable compared with historical balloon angioplasty series. Despite the slight increase of in-hospital cardiac mortality in women, new-device angioplasty is a safe and effective treatment strategy for women with symptomatic coronary artery disease. With the increasing use of intracoronary stents, reassessing women’s procedural risk after stenting is warranted.
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